SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Amendment No. 1)
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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|Item 8.01||Other Events|
As previously disclosed, on July 23, 2019, Nektar received a General Advice letter (“Letter”) from the U.S. Food and Drug Administration (“FDA”) regarding Nektar’s New Drug Application (“NDA”) for NKTR-181, a novel mu-opioid analgesic drug candidate.
In the Letter, the FDA stated that it is postponing product-specific advisory committee meetings for opioid analgesics, including the one previously scheduled for August 21, 2019 to discuss the NDA for the NKTR-181 product, while the agency continues to consider a number of scientific and policy issues relating to this class of drugs. The Letter stated that the FDA’s reason for postponing the advisory committee meeting for NKTR-181 is not unique to the NKTR-181 product. The Letter further stated that the FDA will continue to review the NDA for NKTR-181 and will request additional information from Nektar, as needed. However, the FDA did indicate in the Letter that it is possible the agency may not be able to meet the Prescription Drug User Fee Act (“PDUFA”) goal date of August 29, 2019, due to the postponement of the advisory committee meeting.
As of the date and time of this filing, Nektar has not received an action letter from the FDA regarding Nektar’s NDA for NKTR-181, thereby resulting in the FDA not meeting the PDUFA goal date of August 29, 2019.
Nektar will continue to work closely with the FDA as they continue their review of the NDA for NKTR-181.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date:||August 29, 2019||By:||/s/ Mark A. Wilson|
|Mark A. Wilson|
|General Counsel and Secretary|